Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes (R-LAST)

March 13, 2024 updated by: Dr Constance FLAMAND-ROZE, Versailles Hospital

This is a bi-centric study whose main objective is the validation of a rapid screening test for language disorders in the acute phase of right hemisphere stroke.

Primary objective

The main objective is the validation of a rapid language disorder screening tool that will be used in the acute phase of right hemispheric stroke.

Secondary objectives

Secondary objectives are:

  • Characterize the "atypical crossed aphasia" since the acute phase of stroke with a large cohort of patients , which, to our knowledge, has never been done.
  • Re-evaluate the number of patients with acute language disorder in right hemisphere stroke.
  • Validate the use of R-LAST by different categories of carers

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The R-LAST (Right Language screening test) comprises 8 subtests and a total of 15 items.

Validation will focus on the internal validity (no ceiling or floor effect, no redundancy, internal consistency), the external validity (against a "gold standard" in order to evaluate its specificity and its sensitivity) and the interclass agreement of R-LAST. The median time to administrate de scale will be calculated.

The investigators will validate the scale by administering it to 300 consecutive patients within 24 hours after admission to our 2 stroke units (Centre Hospitalier de Versailles and Centre hospitalier du sud francilien) and to 100 stabilized patients with and without atypical crossed aphasia using the MEC-P evaluation as a reference.

Patients must be 100% right-handed (Edinburgh test), be of French mother tongue, have no history of neurological disease, have no sensory disturbances (blindness, deafness) and no mirror crossed aphasia detected by the LAST (minimum score of 14/15 with a loss point granted for the "automatic speech" subtest, potentially stranded in right strokes)

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Corbeil-Essonnes, France, 91106
        • CH SUd Francilien
      • Le Chesnay, France, 78150
        • CH de Versailles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients must be the age of majority
  • Patients with right hemispheric stroke in the acute phase (internal validation + inter-examiner validation) or stabilization phase (external validation) confirmed by MRI or CT when MRI contraindicated
  • Patient with no "mirror" crossed aphasia detected by the LAST procedure (A or B): LAST> 14
  • Patients who read the newsletter
  • Affiliation to a social security scheme

Criteria Exclusion:

  • Minor patients
  • No French speakers
  • Patients with a history of stroke
  • Patients with dementia
  • Patients with sensory impairment: deafness, blindness
  • Patient not 100% right handed in the Edinburgh questionnaire
  • Inability to answer the Edinburgh Laterality Questionnaire and absence of any person to fill in the questionnaire.
  • Patient with a left-handed person in its family
  • Illiterate patients
  • Patient presenting a "mirror" crossed aphasia detected by LAST A or B (score tolerated: 14/15 with error accepted to the automatic speech)
  • Inability to receive the information letter about the protocol and to read the newsletter
  • Refusal of the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute and subacute phase of right stroke

The intervention will be the passation of Right Language Screening Test (R-LAST).

Patients in acute phase of right hemispheric stroke will be used for the internal validation and the integrated reliability of the Right Language screening test.

Patients in subacute phase of right hemispheric stroke will be used for the external validation of the Right Language screening test.

Validation of the Right Language screening test in acute and subacute phase of right stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score at R-LAST
Time Frame: Day 1

Internal validation: no item will present effect floor, ceiling or of redundancy.

Validation inter examiner: the score obtained to R-LAST is independent from the examiner.

External validation: the patients detected by gold standard as presenting a speech difficulty bound to a right hemispherical lesion will also be him by R-LAST (no forgery negatives), and that the patients not presenting speech difficulty during the signing of these standard gold will obtain the maximum score to R-LAST (no forgery positive).

Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score at LAST A and B
Time Frame: Day 1
Detect the patients presenting a right hemispherical AVC with crossed aphasia "mirror"
Day 1
Time of signing R-LAST
Time Frame: Day 1
To obtain an average time of signing which will have to be shorter than that of the standard gold used during the external validation.
Day 1
Simplicity and convenience of R-LAST
Time Frame: Day 1
Contains only a sheet printed in black and white and both sides (to avoid the semantic indications bound to the color of an item, and to simplify the reproduction).
Day 1
Visual aspect of R-LAST
Time Frame: Day 1
Presentation in "portrait" mode, so that patients presenting a neurovisual disorder of type héminégligence or héminanopsie controlatérale are not penalized
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Didier SMADJA, Neurologist, Sud Francilien Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2018

Primary Completion (Actual)

June 8, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

July 2, 2018

First Submitted That Met QC Criteria

August 5, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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